Severe sepsis with disseminated intravascular coagulation (DIC)
Conditions
Interventions
The rhTM group When the patients with severe sepsis are diagnosed DIC (the acute DIC), they are injected intravenously with recombinant human soluble thrombomodulin (rhTM) within 24 hrs after the dia
Surviving sepsis campaign 2008"
on the patients in both the rhTM group and the control group.
Sponsors
The ethics committees of National Center For Global Health and Medicine, Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The patients with severe sepsis or septic shock admitted to the National Center For Global Health and Medicine, Japan 2) 1) and the patients were diagnosed DIC using the acute DIC criteria within 24 hrs after the admission.
Exclusion criteria
Exclusion criteria: 1. The patients who have the need for the emergency surgery. 2. The patients and/or their family who refuse the intensive care (intratracheal intubation, mechanical ventilation, administration of catecholamine, etc.). 3. The patients who have intracranial bleeding, pulmonary hemorrhage, gastrointestinal hemorrhage (persistent hematemesis, persistent hemorrhagic stool or persistent bleeding from gastrointestinal ulcer). 4. The patients who have fulminant hepatic failure, decompensated cirrhosis, or other sever hepatic diseases. 5. The patients who have allergies to rhTM 6. The pregnant women, or the patients who have the possibility of pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the survival rate after the 28 hospital days and 3 month. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. SOFA score, MODS score 2. CRP value, platelet value, FDP value, D-dimer value 3. Duration of administration of catecholamine 4. Total fluid value until stopping administration of catecholamine 5. The volume of blood transfusion until 72 hours and the total volume until the discharge (RBC volume, FFP volume, platelet volume) 6. Duration of mechanical ventilation 7. The survival rate of 72 hours | — |
Countries
Japan
Contacts
Public ContactAkiyoshi Hagiwara
National Center For Global Health and Medicine, Japan Emergency Medicine and Critical Care
Outcome results
None listed